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Short-term Effects of Ventilation Tubes in Children With Chronic Otitis Media With Effusion

NCT06100159 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-16

No results posted yet for this study

Summary

The goal of this clinical, randomized trial is to compare the sleeping patterns and quality of life of children with chronic otitis media with effusion (OME) with or without tympanic tubes insertion. The main questions it aims to answer are:

* Does tympanic tube insertion have an effect on sleep quality in children with chronic OME?
* Does tympanic tube insertion improve the quality of life for the children with chronic OME and their caregivers?

Participants will have their movements during sleep and number of awakenings measured by an accelerometer placed on their wrist for 7 nights before and after tympanic tube insertion. Their caregivers will answer questionnaires regarding quality of life on behalf of the child. Researchers will compare with a control group of children who also is diagnosed with chronic OME. They will also have their sleep monitored for 7 nights and their caregivers will complete quality of life questionnaires, but the will not receive a tympanic tube. However the control group will be reassessed a month after baseline, and if they still qualify for tympanic tube insertion they will undergo the same routine as the intervention group.

Conditions

  • Otitis Media With Effusion in Children
  • Quality of Life
  • Sleep

Interventions

DEVICE

Tympanostomy tube insertion

Ventilation tube insertion in the tympanic membrane

Sponsors & Collaborators

  • Danish Medical Association

    collaborator OTHER

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Preben Homoee, MD · Zealand University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-20
Primary Completion
2022-06-30
Completion
2022-08-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06100159 on ClinicalTrials.gov